Application of Risk Management - ISO 14971:2007(E) Medical Devices

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Gert Sorensen

#11
Re: ISO 14971:2007(E) Medical devices — Application of risk

Does anyone have a copy of ISO 14971-:cfingers: .
Yes, of course there are. Among others I can mention: Danish Standards Association and IHS. It does not cost more than app. 50$ so it is hardly worth not buying.

Please refrain from asking for copies of copy right protected material. We do not endorse this. :bigwave:
 
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J

JohnM

#12
Re: ISO 14971:2007(E) Medical devices — Application of risk

Wow, $50 is a good deal. I paid a lot more.

I'm stuck on the requirement for the risk management to be an input to product specifications. How do you evaluate the risk on something before you know what it is you are making?

My thought was to have the draft version of the hazard analysis be a part of design phase 1 and the final hazard analysis along with the FMEA being part of design phase 2.

Any thoughts?
 
G

Gert Sorensen

#13
Re: ISO 14971:2007(E) Medical devices — Application of risk

Wow, $50 is a good deal. I paid a lot more.
You're right, I hit the $ sign, should have been £. Still is cheap though. :)

I'm stuck on the requirement for the risk management to be an input to product specifications. How do you evaluate the risk on something before you know what it is you are making?
When you put it like that I have to agree. If you have no grasp of what it is you are going to produce, then of course you cannot evaluate the risk involved. :notme:

My thought was to have the draft version of the hazard analysis be a part of design phase 1 and the final hazard analysis along with the FMEA being part of design phase 2.
And, presto, by now you do know what you are going to produce.... FMEA is your friend. A good FMEA in the design phase will give you the opportunity to improve your design, by reducing or removing potential problems. The problems that are not being "R or R'ed" will be highlighted and that is input for your process and your process control.
:bigwave:
 
R

ron_whitehead - 2009

#14
Re: ISO 14971:2007(E) Medical devices — Application of risk

Design is already done when I start the mfg. process.
Should this risk assessment be the responsibility of the design activity?


Anyone with a good idea or developed risk management tool? I am interested in incorporating this for the initial assessment of the process for manufacturing and the continued residual risk evaluation. My plan is to incorporate the tool into the quality plan.

Thanks
 

Marcelo

Inactive Registered Visitor
#15
Re: ISO 14971:2007(E) Medical devices — Application of risk

John

FMEA should really be used in a late design phase because, as you said, it´s difficult to analyse failure modes of something not yet designed....earlier in the design phase you should use some top-down approach such as Hazop or FTA.

Ron

I think the best use of risk management using it some kind of product life-cycle management (PLM) conformity approach. Risk management isn´t the responsability of the design activity because it has to be used in the product lifecycle.
 
V

Valery

#16
Re: ISO 14971:2007(E) Medical devices — Application of risk

Hello WBubel

Good document!

But i think you really tried to make a guide to a risk management file, not to a risk management report. I´m saying this because you seem to mix the concepts in the document. For example, the POTENTIAL FAILURE, CAUSE OF
FAILURE, EFFECTS OF FAILURE, RESPONSE, RISK INDEX and ACTION TAKEN applies to hazardous situations, not to hazards... hazards are the general "problem", and the hazardous situations are the ways in which the problem can come to pass.

For example:

Patient leakage current is an energy hazard. Thare are X situations in which a potential failure (for example in a component) caused by, for example a wrong line voltage, can lead to a hazardous situation of a patient being exposed to a source of leakage current, which could lead to harm (effects, for example, shock or burn). If the risk of the hazardous situation (potential failure + potential situation + effects) is unacceptable, you have to control the risk (response - for example, limiting the impedance) taking an action, and after that verify that the risk is acceptable (risk index?).

This is the general proccess which have to be performed and recorded in the risk management file. The risk management report, on the other hand, is a summary of the risk management file (the stadard has been revised to remove the traceability requirement on the report because the sizae of reposrt, when you put all the hazardous situations - which are many many many - was too big, which was not the intention of the original requirement).

So, in my opinion, you shoul remove the POTENTIAL FAILURE, CAUSE OF
FAILURE and EFFECTS OF FAILURE (and page 3 too!) as they are not applied to the hazards described. Besides that, you doc lacks the information on implementation of the risk management plan, and the information about methods of obtaining production and post-production information (i´m assuming the RISK INDEX is the acceptable risk defined by the policy of 3.2 a), but i think you´ll have to explicit it better anyway - what you could to is to put a column on "overrall residual risk", and then compare it with the risk index.

Cheers!
Hello Mmantunes,

Could you send me a Risk Management File template? I am in the very beginning of the risk management procedure and would like to be on the right way from the start.
Thank you in advance.
Best regards,
Valery.
 

Marcelo

Inactive Registered Visitor
#17
Re: ISO 14971:2007(E) Medical devices — Application of risk

Hello Valery

I do not have a risk management file template, but you can use the one from WBubel above as a start.

Cheers.
 
J

jkonholm

#18
Re: ISO 14971:2007(E) Medical devices — Application of risk

i'm trying again. but a little bit difference: ISO 14971_2007 voting results (RESULTS OF VOTING AND COMPILATION OF COMMENTS ON
ISO/DIS and IEC/CDV 14971, Medical devices – Application of risk management to medical devices).
and Mr. Gert Sorensen, this is not copyright material. thank you...
Ps: i don't understand if we haven't seen the ISO_DIS docs and how we are think about it!! (and sorry for my worst english) :topic:
 

Attachments

Marcelo

Inactive Registered Visitor
#19
Re: ISO 14971:2007(E) Medical devices — Application of risk

Although ISO and IEC documents that are not drafts are not copyrighted, they are to be used by National Commitees only in the process of standard´s development. You can only have access to these documents through National Commitees and usually if you are participating in the development process. Sharing these documents means that participation is not really necessary and thus weakens the development process (an in countries like Brasil where i live, people want the documents but don´t like to participate).
 
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